Clinical Trial

Clinical trials are conducted to evaluate pharmaceutical, biomedical, vaccination or other health interventions. They are especially important during a disaster or health emergency to improve aid responses and clinical care. However, poorly designed clinical trials may add additional burdens to affected populations. ............. In clinical research, research participants (also called human subjects) are asked to take on the risks of studying an experimental intervention without necessarily receiving any benefits. This feature of clinical trials poses challenges in disaster and humanitarian settings. Ultimately, clinical trials may provide findings that help others in the community or victims of future disasters. This requires balancing individual interests and benefit to others, so it is important to consider what vulnerabilities may exist in the affected population. For instance, certain populations (such as refugees) should not be expected to participate in clinical research unless a clear benefit is expected for that population. For example, it is now viewed as unethical to test treatments in a low-income setting if those populations would be unable to access treatments shown to be beneficial. However, clinical research on a treatment shown to be effective in high-income settings could be important and ethical to conduct in a humanitarian setting to show that it is effective and safe in those settings also. Another ethical consideration is how certain features of daily life in a humanitarian or disaster setting makes participation more costly or risky. Clinical research participation could take significant time away from work, other responsibilities, or opportunities to receive aid. This suggests to some that monetary reimbursement for participation may be ethical, although this is debated. If potential participants lack access to healthcare resources, or if no existing treatments are available, a clinical trial may be seen as their only way to access healthcare. This may pressure them into accepting more risks than they otherwise would. The distinction between clinical care and clinical research can easily be blurred in a public health emergency, creating concerns for coercion and the opportunity for therapeutic misconceptions. Providing benefits while minimizing misconceptions is another important balance in disaster-related clinical trials. More broadly, it is important to consider the effects of clinical research on the community. Clinical trials conducted in humanitarian settings historically did not always return the benefits of the research back to the community; exploitation, therefore, remains a major ethical concern. It is important to operate under organizational transparency while seeking to build or repair trust with communities during clinical research studies.

Which of the following are features of your study?

PREA Version 1.0. This site is under construction. Please continue to check back for more content or leave us a comment on how we can improve.